510(k) K974285

PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT by Perimed, Inc. — Product Code DPW

K974285 is an FDA 510(k) premarket notification submitted by Perimed, Inc. for the device "PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT". The FDA issued a decision of Substantially Equivalent on May 28, 1998. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Perimed, Inc. has at least 9 other 510(k) clearances on record.